Testosterone, The Biggest Men's Health Craze Since Viagra, May Be Risky

Men seek it out to combat low energy and decreased sex drive. Prescription testosterone has become so popular that so-called "low T" clinics are becoming common sights in cities and suburbs.

The number of testosterone prescriptions written in the U.S. more than tripled in the past decade. But researchers suspect that much of the testosterone dispensed at low-T clinics isn't tracked, since it's often bought with cash. This unfettered flow of testosterone — officially a controlled substance — has raised concerns among doctors who specialize in hormonal problems.

"In most doctors' offices, you don't see a big shingle over their door saying, 'Get your testosterone here!' " saysDr. Edward Karpman, a board certified urologist and the medical director of the Men's Health Center at El Camino Hospital in Los Gatos, Calif. Karpman says low-T clinics aren't in the business of treating the complex medical problems that often masquerade as low energy and decreased sex drive. Those can include sleep apnea, depression and, perhaps most importantly, heart disease.

"Any man who presents, especially in his 40s and 50s, with new onset erectile dysfunction is at an increased risk for cardiovascular disease and even heart attack or myocardial infarction," says Karpman.

Hormone treatment itself isn't without risk: A recent study of more than 55,000 men found a doubling of heart-attack risk among older men who used testosterone. Younger men who had a history of heart disease had a higher incidence of nonfatal heart attacks. In addition, men who are on prolonged high-level testosterone replacement therapy can experience testicular shrinkage.

Yet even as calls for closer scrutiny of the treatment intensify, the clinics continue to draw in men like Greg Lucas. At 25, Lucas was single and a rising star at a Dallas software company. But he didn't quite feel right — his energy, his sleep, his libido were all lagging. He was having trouble managing his weight, too.

His symptoms sounded a lot like those described in an advertisement for low testosterone. So Lucas decided to do what the ad recommended: talk to his doctor.

"His first response was, 'OK, let's do a blood test and see where you're at,' " recalls Lucas. "Following that, my blood test returned a rating that was in the normal range for the lab and he said that was fine."

Lucas protested: His levels, after all, were in the bottom 5 percent of normal — that seemed out of step for a 25-year-old man. Lucas was seriously overweight, and his doctor advised him to diet and get more exercise.

The problems persisted, though, and Lucas pressed his doctor for the next three years or so about testosterone treatment. Each time, he got the brushoff.

Lucas did manage to start exercising at a gym, but he wasn't losing much weight. Then a coach mentioned that testosterone treatment could be the answer to his mothballed mojo and suggested he get a second opinion at a low-T clinic. He started searching online and ended up calling a clinic in Dallas. He was impressed. Finally, it seemed, someone was listening to him.

"They did a blood test and found my testosterone level to be even lower than the last time I had it tested, and they said, 'We would absolutely recommend that you start treatment right away,' " Lucas says.

Lucas says the testosterone therapy changed his life: He lost weight and got his energy back. He only wishes his regular doctor would treat him for low T, so that his insurance would cover the bills.

Despite Lucas' positive experience, the risks and health benefits of long-term testosterone therapy are not well understood. The Food and Drug Administration is reassessing the safety of testosterone products. A spokesperson reiterated the agency's own guidelines: None of the products approved by the FDA should be prescribed unless low testosterone is associated with a medical condition.

Some doctors warn patients to stay away from low-T clinics. Dr. Bradley Anawalt is one of those doctors. He heads the Hormone Health Network, part of the professional association for endocrinologists which has released clinical guidelines for testosterone therapy.

Anawalt calls the low-T clinics "sex hormone factories" that promote all the potential virtues and great myths about how testosterone may solve all problems. "They're really out to prescribe as much testosterone as they possibly can, and it's not clear that all these practices are completely safe," he says.

But there's no evidence that the clinics are unsafe, either. State medical boards typically investigate only when patients file complaints, and there hasn't been an outpouring of accusations against the clinics. But a review of physicians working for a number of low-T clinics found that very few specialized in urology or endocrinology. Instead, one doctor at a Chicago clinic and another in Fort Lauderdale were anesthesiologists; in Houston, an allergist; in Phoenix, an osteopath; and in Washington, D.C., an obstetrician-gynecologist.

"There is some hope that state or federal governments will start to crack down and regulate unscrupulous prescription of testosterone to men, and perhaps they will review the practices of these clinics," says Anawalt.

The clinics themselves say they're legitimate medical practices. Dr. Bill Reilly is the chief medical officer at Low T Center, one of the largest chains of low-T clinics, based in Southlake, Texas. His company has 45 offices and some 35,000 patients. Reilly says patients must have a diagnosed medical condition.

"Our No. 1 complaint at Low T is, 'Why won't you treat me?' We just don't see a patient, 'Hey, here you go. Here's some testosterone,' " Reilly says. "They go through a complete history, physical, thorough evaluation. We go through their symptoms."

Reilly says some 15,000 men have been turned away from his clinics with no treatment because they don't meet the medical definition of low testosterone. And those with sleep apnea or high blood pressure or other serious illnesses are encouraged to see their family doctor. Before joining Low T Center, Reilly was a joint surgeon. He doesn't believe medical training in urology or endocrinology is necessary to do the job well.

"You don't need to be an endocrinologist. You don't need to be a urologist," says Reilly. "We're all doctors. And we study more about testosterone than they do. We basically follow the national endocrinology guidelines."

Reilly says the growing criticism from others in the medical community is perhaps just ignorance and fear of competition. After all, Low T Center expects to more than double its number of sites in the next year, reaching perhaps as many as 70,000 patients.

Today in Your Health - boosting testosterone. It might be the biggest trend in men's health craze since the release of Viagra.

INSKEEP: We have two reports this morning. First, we'll hear about the so-called low T clinics where men receive prescription testosterone. These clinics are popular. But a recent study found prescription testosterone raised the risk of heart attacks in older men. Some doctors say the clinics are not safe.

Sarah Varney reports.

SARAH VARNEY, BYLINE: By most measures, Greg Lucas should have been in his prime. At 25, he was single and a rising star at a Dallas software company. But Greg didn't quite feel right.

GREG LUCAS: You know, just felt a lack of energy, lack of motivation, had some sleep issues, some libido issues.

VARNEY: His symptoms sounded a lot like those described in a television ad for low testosterone.

(SOUNDBITE OF AN AD)

UNIDENTIFIED MAN #1: Feeling like a shadow of your former self?

UNIDENTIFIED MAN #2: Michael, get in the game.

UNIDENTIFIED MAN #3: Don't have the hots for hoops with you buddies? Lost your appetite for romance?

VARNEY: So Greg decided to do what the ad recommended - talk to his doctor.

LUCAS: His first response was, OK, let's do a blood test and, you know, see where you're at. So, following that, my blood test returned a rating that was within the normal range for the lab. He said that was fine.

VARNEY: Greg protested. His levels, after all were in the bottom 5 percent of normal, a rating that seemed out of step for a 25-year-old man. Greg was seriously overweight though and his doctor advised him to diet and get more exercise.

LUCAS: It's all well and good to say, well, you should go exercise but if you don't feel like doing that, it's not going to happen.

VARNEY: He pressed his doctor for the next three years or so about testosterone treatment, but each time got the brush-off.

LUCAS: It wasn't simply that he said, no, that's not a problem, we're not going to go down that path. It was that I never got any sort of alternative.

VARNEY: Greg did manage to start exercising at a gym but he wasn't losing much weight. Then, a coach mentioned that testosterone treatment could be the answer to his mothballed mojo and suggested he get a second opinion at a low T clinic. He went online and ended up calling a clinic in Dallas. He was impressed.

LUCAS: They did a blood test and found my testosterone level to be even lower that the last time that I had it tested. And they said we would absolutely recommend that you start treatment right away.

VARNEY: Greg says the testosterone therapy changed his life. He lost weight and got his energy back.

Testosterone prescriptions in the U.S. more than tripled in the last decade. But researchers suspect much of the testosterone dispensed at Low T clinics isn't tracked since it's often bought with cash. This unfettered flow of testosterone, officially a controlled substance, has raised concerns among doctors who specialize in hormonal problems.

DR. EDWARD KARPMAN: In most doctors' offices, you don't see a big shingle over their door saying: Get your testosterone here.

VARNEY: Dr. Edward Karpman is a board certified urologist and the medical director of the Men's Health Center at El Camino Hospital in Los Gatos, California. Karpman says low T clinics aren't in the business of treating the complex medical problems that often masquerade as low energy and decreased sex drive. Those can include sleep apnea, depression and, perhaps most importantly, heart disease.

KARPMAN: Any man who presents, especially in his 40s and 50s, with new on-set erectile dysfunction is at an increased risk for cardiovascular disease and even heart attack.

VARNEY: Hormone treatment itself isn't without risk. A recent study of more than 55,000 men found a doubling of heart attack risk among older men who used testosterone. Younger men who had a history of heart disease had a higher incidence of non-fatal heart attacks. In addition, men who are on prolonged high level testosterone replacement therapy can experience testicular shrinkage.

Some doctors warn patients to stay away from low T clinics. Dr. Bradley Anawalt is one of them. He heads the Hormone Health Network, part of the professional association for endocrinologists which has released clinical guidelines for testosterone therapy.

DR. BRADLEY ANAWALT: They are sex hormone factories. And what I mean by that is they're out to promote all of the potential virtues and great myths about how testosterone may solve all male problems. And they're really out to prescribe as much testosterone as they possibly can. And it's not clear that all these practices are completely safe.

VARNEY: But there's no evidence they're not safe. State medical boards typically investigate only when patients file complaints, and there hasn't been an outpouring of accusations ns against the clinics. But a review of physicians working for a number of low T clinics found very few specialized in urology or endocrinology.

ANAWALT: At some point state or federal governments will begin to crack down and regulate unscrupulous prescription of testosterone to men. And perhaps they will review the practices of these clinics.

VARNEY: The clinics themselves say they're legitimate medical practices. Dr. Bill Reilly is the chief medical officer at Low T Center, one of the largest chains of low T clinics based in Southlake, Texas. His company has 45 offices and some 35,000 patients. Reilly says patients must have a diagnosed medical condition.

DR. BILL REILLY: 'Cause our number one complaint at Low T is, you know, why won't you treat me? We just don't see a patient and say hey, here you go, here's some testosterone. They go through a complete history, physical, thorough evaluation. We go through their symptoms.

VARNEY: Indeed, Reilly says some 15,000 men are turned away with no treatment because they don't meet the medical definition of low testosterone. And those with sleep apnea or high blood pressure or other serious illnesses are encouraged to see their family doctor. Before joining Low T Center, Reilly was a joint surgeon. He doesn't believe medical training in urology or endocrinology is necessary to do the job well.

REILLY: You don't need to be an endocrinologist. And you don't need to be an urologist. We're all doctors. And we study more about testosterone than they do. We basically follow the national endocrinology guidelines.

VARNEY: Reilly says the growing criticism from others in the medical community is perhaps just ignorance and fear of the competition. After all, Low T Center expects to more than double its sites in the next year, reaching perhaps as many as 70,000 patients.

Still, the risks and health benefits of long-term testosterone therapy are not well understood. The Food and Drug Administration is reassessing the safety of testosterone products. A spokesperson reiterated the agency's own guidelines; none of the products approved by the FDA should be prescribed unless low testosterone is associated with a medical condition.